The FDA has increased its scrutiny on manufacturers who outsource products and processes.  Are you prepared to face this attention?

This course provides interactive team workshops and class discussions involving purchasing controls, outsourcing, and supply chain management throughout the total product life cycle.  Participants will benefit from hands-on experience involving the interpretation and practical application of requirements as specified by the FDA and its global counterparts.   

Course Objectives

• Understand the purpose, benefits, and objectives of purchasing controls and outsourcing as they relate to supply chain management.
• Learn how to interpret and apply FDA, ISO, and other international requirements.
• Comprehend the interdependencies associated with integrating outsourced processes within a functioning quality management system.
• Examine organizational definition and alignment of roles, responsibilities, authorities, and accountability for establishing purchasing controls, from planning supplier evaluation and qualification to acceptance activities and monitoring of supplier performance.
• Understand the relationship among outsourced processes, risk management, and supply chain management.
• Evaluate risks, consequences, and impacts of outsourcing, purchasing, and supply chain activities relevant to customers, suppliers, and other interested parties.
• Learn to identify, select, and utilize valid statistical techniques and methods for analyzing data and information.

Topics

• Purchasing control and outsourcing requirements:  regulations, standards, and guidance
• Key aspects associated with the process of procurement and supply chain management, including supplier selection, evaluation, and acceptance, including capacity to meet specified requirements
• Recent FDA inspectional observations and trends

Who Should Attend

This course is intended for personnel from research and development, engineering, manufacturing, quality, and regulatory, as well as other professionals having direct involvement in the procurement of material and/or services as part of supply chain management and the commercialization of a product or service.  This course would also benefit anyone having a functional responsibility for managing purchasing-related activities associated with a quality management system.

CEUs: 1.5
Days: 2